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Pharmaceutical manufactures are encouraged to set up coding rules and guidelines when using medical terminologies. This is particularly recommended for the MedDRA dictionary. A guidelines document “points to consider” was created to help pharmaceutical manufacturers, clinical investigators and other users achieve consistency in the manner in which they assign terms when using MedDRA. It is currently available for comment through the MedDRA Maintenance and Support
Services Organization (MSSO) homepage.
Adverse Drug Reaction Dictionaries
Services Organization (MSSO) homepage.
Adverse Drug Reaction Dictionaries
MedDRA Version 16.0
MedDRA Term Selection: Points to Consider Release 4.5 (pdf)
MedDRA Term Selection: Points to Consider Release 4.5 (doc)
MedDRA Term Selection: Points to Consider Release 4.5 (HTML)
MedDRA Data Retrieval and Presentation: Points to Consider Release 3.5 (pdf)
MedDRA Data Retrieval and Presentation: Points to Consider Release 3.5 (doc)
Introductory Guide MedDRA Version 16.0
Introductory Guide for Standardised MedDRA Queries (SMQs)
MedDRA Distribution File Format Document Version 16.0
MedDRA Version 15.1
MedDRA Term Selection: Points to Consider Release 4.4 Based on MedDRA Version 15.1
MedDRA Data Retrieval and Presentation: Points to Consider Release 3.4 Based on MedDRA Version 15.1.
Introductory Guide MedDRA Version 15.1
Introductory Guide for Standardised MedDRA Queries (SMQs) Version15.1
MedDRA ASCII and Consecutive Files Documentation Version 15.1
WHODRUG
The WHO Drug Dictionary is a computer register containing information on all drugs mentioned on adverse reaction reports submitted by countries participating in the WHO International Drug Monitoring Programme from 1968 onwards. This makes the WHO Drug Dictionary a unique source of drug names from all major pharmaceutical markets - of both single and multiple ingredient drug.
WHO Drug Dictionary.
WHO Drug Dictionary Enhanced.
WHO Herbal Dictionary.
Using the WHO Drug Dictionary for Reporting Clinical Trials.
Who Drug Best Practices document:
In 2011 the UMC together with the user community has focused on optimizing the way the dictionaries are used. A new guideline of Best Practices has been developed; it describes how you can use the dictionaries in certain coding situations and also how to guide you to find the best match in the dictionaries. The documents are based on input from users and are currently only drafts. The User Guide, Best Practices, Minutes and materials from the User Group Meetings and the latest updates in the WHO Drug Dictionaries can be accessed, and downloaded through the Uppsala Monitoring Centre web site
- Guidelines for ATC classification and DDD assignment 2013
- Guidelines for ATC classification and DDD assignment 2011
INTERNATIONAL MEDICAL TERMINOLOGY (IMT)
The International Medical Terminology (IMT) is a medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. The foundation of the IMT is the Medical Dictionary for Drug Regulatory Affairs (MEDDRA) developed by the UK Medicines Control Agency (MCA) in its Adverse Drug Reactions On-line Information Tracking System (ADROIT).
Included in the IMT are terms describing diseases, diagnoses, signs, symptoms, therapeutic indication names, and qualitative results of investigations (such as laboratory tests, radiological studies), medical and surgical procedures, and terms describing medical, social, and family history. The IMT consists of a five level hierarchy, starting with 26 System Organ Classes (SOCs), that represent the highest level groupings of the terminology. Including all levels, it contains approximately 40,000 terms. The Preferred Term (PT) is the internationally agreed upon level at which regulatory information is to be exchanged. The IMT contains approximately 8,800 Preferred Terms.
INTERNATIONAL CLASSIFICATION OF DISEASES (ICD)
The International Classification of Diseases (ICD) is the archetypal coding system for medical record abstraction. It origin is traced to the International List of Causes of Deaths, adopted in 1893 by the International Statistical Institute. The
classification has been revised at (approximately) ten-yearly intervals. The World Health Organisation (WHO) has undertaken their maintenance and updating since 1948. Its scope was then extended to include non-fatal conditions.
Subsequent revisions have enhanced its usefulness for morbidity applications.
The Ninth Edition (ICD-9) was published in 1977 and the Tenth Edition in 1992. After the publication of ICD-9, some problems were detected. The United States National Centre for Health Statistics published a set of "clinical modifications" to ICD-9 known as ICD-9 CM. Many countries for a number of purposes have adopted the ICD-9-CM, widely accepted and used in the healthcare industry,: data collection, quality of care analyses, resource utilisation, research and reimbursement, and statistical reporting.
WHOART
This terminology has been developed over more than 30 years to serve as a basis for rational coding of adverse reaction terms. Because new drugs and new indications produce new terms to be incorporated, the structure of the terminology is flexible enough to allow new developments to be incorporated without losing previous relationships.
WHO-ART Dictionary guide 2001
WHO-ART Dictionary guide 2005
COSTART
Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) is the terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. It provides a method to deal with the variation in vocabulary used by those who submit adverse event reports to the FDA. Three new COSTART terms were added to this version and are integrated throughout the manual in the appropriate indexes. Most changes made were to the Glossary file.
Dictionaries and Coding in Pharmacovigilance
MedDRA Term Selection: Points to Consider Release 4.5 (doc)
MedDRA Term Selection: Points to Consider Release 4.5 (HTML)
MedDRA Data Retrieval and Presentation: Points to Consider Release 3.5 (pdf)
MedDRA Data Retrieval and Presentation: Points to Consider Release 3.5 (doc)
Introductory Guide MedDRA Version 16.0
Introductory Guide for Standardised MedDRA Queries (SMQs)
MedDRA Distribution File Format Document Version 16.0
MedDRA Version 15.1
MedDRA Term Selection: Points to Consider Release 4.4 Based on MedDRA Version 15.1
MedDRA Data Retrieval and Presentation: Points to Consider Release 3.4 Based on MedDRA Version 15.1.
Introductory Guide MedDRA Version 15.1
Introductory Guide for Standardised MedDRA Queries (SMQs) Version15.1
MedDRA ASCII and Consecutive Files Documentation Version 15.1
WHODRUG
The WHO Drug Dictionary is a computer register containing information on all drugs mentioned on adverse reaction reports submitted by countries participating in the WHO International Drug Monitoring Programme from 1968 onwards. This makes the WHO Drug Dictionary a unique source of drug names from all major pharmaceutical markets - of both single and multiple ingredient drug.
WHO Drug Dictionary.
WHO Drug Dictionary Enhanced.
WHO Herbal Dictionary.
Using the WHO Drug Dictionary for Reporting Clinical Trials.
Who Drug Best Practices document:
In 2011 the UMC together with the user community has focused on optimizing the way the dictionaries are used. A new guideline of Best Practices has been developed; it describes how you can use the dictionaries in certain coding situations and also how to guide you to find the best match in the dictionaries. The documents are based on input from users and are currently only drafts. The User Guide, Best Practices, Minutes and materials from the User Group Meetings and the latest updates in the WHO Drug Dictionaries can be accessed, and downloaded through the Uppsala Monitoring Centre web site
- Guidelines for ATC classification and DDD assignment 2013
- Guidelines for ATC classification and DDD assignment 2011
INTERNATIONAL MEDICAL TERMINOLOGY (IMT)
The International Medical Terminology (IMT) is a medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. The foundation of the IMT is the Medical Dictionary for Drug Regulatory Affairs (MEDDRA) developed by the UK Medicines Control Agency (MCA) in its Adverse Drug Reactions On-line Information Tracking System (ADROIT).
Included in the IMT are terms describing diseases, diagnoses, signs, symptoms, therapeutic indication names, and qualitative results of investigations (such as laboratory tests, radiological studies), medical and surgical procedures, and terms describing medical, social, and family history. The IMT consists of a five level hierarchy, starting with 26 System Organ Classes (SOCs), that represent the highest level groupings of the terminology. Including all levels, it contains approximately 40,000 terms. The Preferred Term (PT) is the internationally agreed upon level at which regulatory information is to be exchanged. The IMT contains approximately 8,800 Preferred Terms.
INTERNATIONAL CLASSIFICATION OF DISEASES (ICD)
The International Classification of Diseases (ICD) is the archetypal coding system for medical record abstraction. It origin is traced to the International List of Causes of Deaths, adopted in 1893 by the International Statistical Institute. The
classification has been revised at (approximately) ten-yearly intervals. The World Health Organisation (WHO) has undertaken their maintenance and updating since 1948. Its scope was then extended to include non-fatal conditions.
Subsequent revisions have enhanced its usefulness for morbidity applications.
The Ninth Edition (ICD-9) was published in 1977 and the Tenth Edition in 1992. After the publication of ICD-9, some problems were detected. The United States National Centre for Health Statistics published a set of "clinical modifications" to ICD-9 known as ICD-9 CM. Many countries for a number of purposes have adopted the ICD-9-CM, widely accepted and used in the healthcare industry,: data collection, quality of care analyses, resource utilisation, research and reimbursement, and statistical reporting.
WHOART
This terminology has been developed over more than 30 years to serve as a basis for rational coding of adverse reaction terms. Because new drugs and new indications produce new terms to be incorporated, the structure of the terminology is flexible enough to allow new developments to be incorporated without losing previous relationships.
WHO-ART Dictionary guide 2001
WHO-ART Dictionary guide 2005
COSTART
Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) is the terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. It provides a method to deal with the variation in vocabulary used by those who submit adverse event reports to the FDA. Three new COSTART terms were added to this version and are integrated throughout the manual in the appropriate indexes. Most changes made were to the Glossary file.
Dictionaries and Coding in Pharmacovigilance